Biologics Contract Manufacturing Market

Biologics Contract Manufacturing Market

Global Biologics Contract Manufacturing Market reached US$ YY million in 2022 and is expected to reach US$ YY million by 2030, growing with a CAGR of YY % during the forecast period 2024-2031.

The ""biologics contract manufacturing"" represents the practice of contract manufacturing organisations (CMOs) that manage the production of biologics, or biopharmaceutical products. Complex medicinal medications known as biologics are generated from living things, including cells, proteins, antibodies, and nucleic acids. They are employed in the treatment of a number of illnesses, including as autoimmune diseases, cancer, and genetic disorders.

Manufacturing biologics is a complex and highly specialised process that calls for advanced technology, expert knowledge, and strict quality control procedures. Several biotechnology and pharmaceutical companies choose to collaborate with specialised contract manufacturing firms in order to take use of their resources and expertise. CMOs benefit from economies of scale and specialized expertise, leading to potential cost savings for the client.

Market Dynamics: Drivers and Restraints

Rising demand for vaccines and monoclonal antibodies

Developing and maintaining in-house biologics manufacturing capabilities can be cost-prohibitive for many companies. By outsourcing to CMOs, companies can avoid significant capital expenditures, reduce operational costs, and improve overall cost efficiency. This is especially crucial for companies looking to allocate resources strategically and focus on core competencies such as research and development.

Additionally, the strategies followed by the companies also helps to boost the market growth. For instance, on August 15, 2023, AGC Biologics, stated that a new agreement with Asahi Kasei Pharma Corporation to produce clinical drug substance for antibody-based therapies at AGC Biologics’ Seattle manufacturing site. Under the agreement, AGC Biologics will leverage its monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei Pharma drug substance.

Moreover, in July 2023, in India, Syngene acquired a multimodal biologics drug substance production facility from Stelis Biopharma. With this acquisition, Syngene gains an additional 20,000 L of installed capacity for the manufacture of biologic medicinal substances. The acquired facility was initially constructed to produce COVID-19 vaccines, but Syngene plans to repurpose and revalidate it for the production of monoclonal antibodies.

Market Dynamics: Restraint

Stringent regulatory requirements

Strict regulations can impose significant challenges and constraints on the biologics contract manufacturing market. While regulations are crucial for ensuring the safety, efficacy, and quality of biologics, they can also create barriers that impact the growth and operation of contract manufacturing organizations.

However, regulatory standards and requirements may vary significantly among different countries and regions. Harmonizing regulatory frameworks globally remains a challenge, and CMOs must adapt to and comply with diverse sets of regulations, adding complexity to their operations.

For instance, regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other health authorities globally have increased scrutiny on biologics manufacturing. This includes strict adherence to Good Manufacturing Practice (GMP) guidelines and other regulatory standards to ensure the safety, efficacy, and quality of biologic products. Thus above factors restrain the market growth.

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Segment Analysis

The global biologics contract manufacturing market is segmented based on product, platform, application, end-user and region.

The monoclonal antibodies segment from the product segment accounted for approximately 39.7% of biologics contract manufacturing share

Monoclonal antibodies have become a crucial class of therapeutics for various diseases, including cancer, autoimmune disorders, and infectious diseases. The increasing recognition of their efficacy and specificity in targeting specific biomolecules or cells has driven the demand for mAbs in the pharmaceutical industry.

Thus rise of cancer cases helps to acclerates the segment growth. For instance, according to WHO 2022, estimated that, cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths. Around one-third of deaths from cancer are due to tobacco use, high body mass index, alcohol consumption, low fruit and vegetable intake, and lack of physical activity.

Additionally, the strategies like partnerships and acquisitions followed by the companies helps to boost the segment growth. For instance, in December 2023, KBI Biopharma, Inc., a JSR Life Sciences company, had launched SUREmAb, an offering built on KBI’s SUREtechnology Platform designed for optimized, safe, and cost-efficient monoclonal antibody (mAb) development and manufacturing.

Geographical Analysis

North America accounted for approximately 39.27% of the market share in 2023

U.S. is a global hub for biotechnology and pharmaceutical innovation. The presence of numerous biotech and pharmaceutical companies, research institutions, and academic centers with a focus on biologics has led to a surge in the development of biologic drugs. Contract manufacturing services play a crucial role in supporting the manufacturing needs of these entities. The strategies like acquisitions and partnerships followed by the companies also help to accelerate the region growth.

For instance, on April 11, 2022, Recipharm, stated the closing of its acquisitions of advanced therapy CDMO Arranta Bio and virotherapy CDMO Vibalogics. The acquisitions reflect Recipharm’s strategy of building its presence in the Biologics market, with a particular focus on drug substance manufacturing of novel ATMPs (advanced therapy medicinal products).

Additionally, on November 13, 2023, Ajinomoto Co., Inc and Forge Biologics (Forge), had entered into a definitive agreement by which Ajinomoto Co., will acquire Forge, a leading manufacturer of genetic medicines, in an all-cash deal for $620 million. Forge is a viral vector and plasmid contract development and manufacturing organization (CDMO) and clinical-stage therapeutics company, enabling access to potentially life-changing gene therapies by bringing them from concept to reality.

COVID-19 Impact Analysis

The urgent need for COVID-19 vaccines led to a surge in demand for biologics contract manufacturing services. Companies involved in vaccine development sought external partners to scale up production rapidly. Some contract manufacturing organizations pivoted their operations to prioritize COVID-19 vaccine production, contributing to the global vaccination efforts.

The wave of investment in viral vector manufacturing began before the pandemic, although of course the need for adenovirus for COVID-19 recombinant vector vaccines has intensified demand. Even before the pandemic, there was a bottleneck in cell and gene therapy manufacturing, especially for production of viral vectors.

This will only be exacerbated as some of the coming wave of pipeline advanced therapies is approved – there are almost 3,000 gene therapies and gene-modified cell therapies in development from discovery to clinical stage. So, contract manufacturing organizations investing in virus manufacturing now for COVID-19 recombinant vector vaccines will be able to use these facilities for regenerative medicines in future.

Market Segmentation

By Product
• Monoclonal Antibodies
• Recombinant Proteins
• Insulin
• Vaccines
• Others

By Platform
• Mammalian
• Microbial

By Application
• Oncology
• Metabolic Diseases
• Autoimmune Diseases
• Ophthalmology
• Infectious Diseases
• Cardiovascular Diseases
• Others

By End-user
• Pharmaceutical companies and Biotechnology companies
• Contract Manufacturing Organizations
• Academic and Research Institutes

By Region
• North America
U.S.
Canada
Mexico
• Europe
Germany
UK
France
Italy
Spain
Rest of Europe
• South America
Brazil
Argentina
Rest of South America
• Asia-Pacific
China
India
Japan
Australia
Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

The major global players in the market include Wuxi Biologics, AGC Biologics, Lonza, KBI Biopharma, Vetter Pharma, Boehringer Ingelheim GmbH, Abzena Ltd, Samsung Biologics, Eurofins CDMO, Catalent among others.

Key Developments
• In December 2022, Global pharma giants GSK, Sanofi and Takeda had signed on with with a partnership of agencies to advance biologic manufacturing in Singapore. The production partnership is through the Biologics Pharma Innovation Programme Singapore (BioPIPS), which is a consortium started by A*STAR with support from the Singapore Economic Development Board.
• In January 2023, Lotte Biologics stated the blueprint to leap forward as a global contract development and manufacturing organization (CDMO). The company plans to invest a total of $3 billion (approximately KRW 3 trillion) by 2030 to construct three mega plants with a total production capacity of 360,000 liters of antibody drugs in Korea. Each plant will be capable of producing 120,000 liters of antibody drugs, with additional expansion plans calling for a small-scale incubator for clinical drug substance production as well as a commercial drug product production facility.

Why Purchase the Report?
• To visualize the global biologics contract manufacturing market segmentation based on product, platform, application, end-user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of biologics contract manufacturing market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global biologics contract manufacturing market report would provide approximately 69 tables, 58 figures and 187 Pages.

Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies